Type 1 Diabetes
Conditions
Keywords
diabetes, insulin, blood sugar, type 1 diabetes, insulin dependent diabetes, transdermal
Brief summary
This study is designed to evaluate the pharmacokinetics/pharmacodynamics of an investigational basal insulin patch in type 1 diabetes patients.
Detailed description
The study is looking for patients that meet the following criteria: * Duration of type diabetes greater than or equal to 10 years * HbA1C less than or equal to 9.0% * C-peptide negative * Ages 18 - 65, male or female * Body Mass Index (BMI) 18.5 - 32 * Non-smoker * No advanced diabetes complications * Not pregnant or breast feeding
Interventions
OTHERPassPort(R) Transdermal Insulin Delivery System
The PassPort(R) Transdermal Insulin Delivery System is a drug-device combination product used to create micropores in the skin to enable transdermal delivery of insulin.
Sponsors
Altea Therapeutics
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Duration of type 1 diabetes greater than or equal to 10 years * HbA1c less than or equal to 9.0% * C-peptide negative * Ages 18 - 65, male or female * BMI 18.5 - 32 * Non- smoker * No advance diabetes complications * Not pregnant or breast feeding
Exclusion criteria
* Arm or leg rashes, open wounds, or skin conditions * Psychiatric disorders * Participation in a clinical research trial in last 3 months * Clinically significant acute illness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax) | Samples were collected at -1,-0.25, 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 12.5, 13.0, 14.0, 15.0, 16.0 hours | Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PK was determined by analysis of serum insulin assay values. The mean Cmax was reported. |
| Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax) | Glucose infusion rates were adjusted every 10 minutes as necessary | Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PD was determined by analysis of glucose infusion rates required to maintain the glucose clamp level of 100 mg/dL. The mean GIRmax was reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients | Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal | Skin response was evaulated by visual skin scoring using a modified Draize scale and transepidermal water loss (TEWL) measurements. The transdermal insulin patch was well-tolerated with mild transient erythema at the application site. |
Countries
United States
Participant flow
Recruitment details
Subjects for the IN2007001 study were recruited between August 2007 and November 2007 by the Phase 1 Clinical Research Unit.
Pre-assignment details
Subjects stopped intermediate/long-acting insulin 48 hours prior to treatment or discontinued use of their insulin pump when they arrived for the treatment. There was a run-in period in which IV insulin lispro was administered to achieve a glucose clamp target of 100 mg/dL prior to application of the patch.
Participants by arm
| Arm | Count |
|---|---|
| Transdermal Patch PassPort(r) Transdermal Insulin Delivery System | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Transdermal Patch |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Age Continuous | 35.4 years STANDARD_DEVIATION 10.8 |
| Region of Enrollment United States | 9 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax)
Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PD was determined by analysis of glucose infusion rates required to maintain the glucose clamp level of 100 mg/dL. The mean GIRmax was reported.
Time frame: Glucose infusion rates were adjusted every 10 minutes as necessary
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transdermal Patch | Pharmacodynamics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (GIRmax) | 4.9 mg/kg/min | Standard Error 1 |
Primary
Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax)
Study IN2007001 is designed to evaluate the PK/PD of the PassPort(R) Transdermal Insulin Delivery System in type 1 diabetes patients. The PK was determined by analysis of serum insulin assay values. The mean Cmax was reported.
Time frame: Samples were collected at -1,-0.25, 0, 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10.0, 11.0, 12.0, 12.5, 13.0, 14.0, 15.0, 16.0 hours
Population: Number of subjects completed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transdermal Patch | Pharmacokinetics of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients (Cmax) | 33.0 uU/mL | Standard Error 6.3 |
Secondary
Skin Response to the Application of the PassPort(R) Transdermal Insulin Delivery System in Type 1 Diabetes Patients
Skin response was evaulated by visual skin scoring using a modified Draize scale and transepidermal water loss (TEWL) measurements. The transdermal insulin patch was well-tolerated with mild transient erythema at the application site.
Time frame: Time Points: prior to microporation, after microporation, after patch removal, 24 hours after patch removal, and 7 days after patch removal